知情同意 is the process of voluntary agreement by a fully informed competent person to participate in research.
Potential participants must be given sufficient participant information to allow them to decide whether or not they want to take part in a research study.
Where research involves personal contact with the researcher such as face to face interviews, 焦点小组, 直接观察, physiological measurements or other methods of data collection involving personal contact, participants should be given a participant information sheet (or leaflet) and would normally be asked to sign a consent form. 在大多数情况下, 参与者应主动提供同意, 但在某些情况下，可以使用默示同意, e.g. an online survey that doesn’t collect any personal or sensitive data and is low risk.
A consent form should be a short document (normally one page 但 may need to be longer depending on the complexity of the study) containing explicit statements of what taking part in the research project involves and what will become of the data collected.
的模板 生产参与者信息 includes some standard sections which you cannot omit 但 also sections which you can amend or exclude depending on your study. The guidance will help you produce the participant information by providing further explanation of parts of the participant information.
The advantage of a written Information Sheet is that you and your participants have a record of all the relevant information about the study. 大多数情况下，这是补角, 而不是取代, 研究者和潜在参与者之间的讨论.
对于一些参与者，比如非常小的孩子, a written information sheet is not appropriate (although for children, 他们的监护人应该收到关于研究的书面信息). For other participants the information may be presented in a letter or email rather than as an 'Information Sheet'.
The participant information sheet should be designed so that potential participants of your research project can give informed consent to participate in the project.
- Provide sufficient and appropriate information on which they can base an informed decision, 包括任何风险和好处
- Be written in language that potential participants could reasonably be expected to understand
- Be free from coercive language and promises that cannot be kept or unjustified claims of benefits
- Be provided for each data collection tool separately so if the research involves both interviews and 焦点小组, 每个活动都必须有参与者信息
- 提供给每一组参与者，例如, 学生和员工都能获得与他们相关的信息.
The consent form should have tick boxes to allow the participant to consent to each of the statements and, 在适当的时候, allow the participant not to take part in certain aspects of the study by either agreeing or disagreeing to a statement, e.g. 不同意他们的数据被用于未来的研究. Both the participant and the researcher obtaining consent should sign the form. Two forms should be signed so that the participant can be provided with a signed copy to keep for their records.
Clear evidence must be obtained that the participant has given informed consent to take part in the study. This will normally be in the form of a signed consent form although other evidence may be acceptable (for example by audio recording consent). It is recognised that there are some rare instances when it will not be possible or appropriate to ask for written consent (e.g. where there are cultural or political concerns with signing contract-like documents).
选择同意加入是曼城的首选方法, as Opt-out does not reflect a conscious decision by those invited to accept or decline an invitation to participate in research. Requests for opt-out consent will only be considered in exceptional cases and a full explanation should be provided.
Please bear in mind that the template does not cover all eventualities and needs to be tailored depending on the type of study, 但, 它提出了一些潜在的情况.
- 我确认我已经向我解释了这个项目, 并已阅读参赛资料表, 我可以留作记录吗. I have been given the opportunity to ask questions and have had them answered to my satisfaction.
- If applicable, a statement asking the participant to consent to audio and or video recording.
- 我明白我的参与是自愿的, 我可以选择不参与这个项目的部分或全部, and that I can withdraw at any stage of the project without being penalized or disadvantaged in any way.
- 要求参与者同意City的声明, 十大靠谱网赌平台 recording and processing this information about them and that they understand that the information collected in the study will be used only for the purpose(s) set out in the consent form.
- A statement that asks the participant to confirm that they understand how their data will be handled (e.g. 存储，销毁，共享，它的用途).
In addition to the above it would be expected that explicit consent for the following is obtained where applicable:
- 数据的重用和解释数据的用途, as well as reassurance that the data will only be reused in studies which have been given ethics approval.
- 在研究团队之外共享数据.g. 与合作者).
- 如果使用匿名在线/纸质调查, a statement that asks the participant to confirm that they understand that their data cannot be withdrawn and/or when it is no longer possible to withdraw their data, e.g. 一旦数据被匿名化.
- A statement that asks the participant to confirm that they understand that their anonymous data will be made open access, e.g. 支持期刊出版或满足资金需求.